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Probiotics for Girls With Recurring Urinary Tract Infections

Primary Purpose

Recurrent Urinary Tract Infection

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lactobacillus reuteri DSM 17938
trimethoprim/sulfamethoxazole
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Urinary Tract Infection focused on measuring Urinary Tract Infection, Probiotics, Dietary Supplements, Bacteriuria

Eligibility Criteria

3 Months - 17 Years (Child)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Girls age 1 through age 17 years of age
  • Must have had at least 3 symptomatic UTI, uncomplicated or complicated, in the year preceding study inclusion or already using any form of prophylaxis to prevent recurrences of UTI
  • Must have had at least 3 symptomatic urinary tract infections in the year before the start of the prophylaxis.

Exclusion Criteria:

  • Breastfeeding
  • Pregnancy
  • Prior adverse reaction to sulfa drugs or sulfamethoxazole/trimethoprim
  • Known immunosuppression i.e., transplant recipients or children with congenital immunodeficiencies
  • Poorly controlled diabetes
  • Untreated HIV infection
  • Use of high dose corticosteroids for autoimmune diseases or post-organ transplantation. Inhaled corticosteroids or oral steroids for asthma are allowed.
  • Malnutrition
  • Patients with a history of sulfamethoxazole/trimethoprim-resistant UTI will be excluded from the study
  • Patients with renal insufficiency, liver insufficiency, or cardiopulmonary disease requiring medication will be excluded from the study
  • Patients with known anemia will be excluded from the study
  • Patients taking medications that may interact with sulfamethoxazole/trimethoprim will be excluded from the study
  • Patients taking other probiotics will be excluded from the study
  • Patients already taking prophylactic antibiotics will be excluded from the study

Sites / Locations

  • Texas Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

ARM A

ARM B

Arm Description

Probiotics drops plus placebo elixir

TMP/SMZ elixir plus placebo drops

Outcomes

Primary Outcome Measures

The primary outcome will be the rates of bacteriuria among the subjects and the comparison of the two arms.

Secondary Outcome Measures

Full Information

First Posted
November 10, 2008
Last Updated
August 14, 2020
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00789464
Brief Title
Probiotics for Girls With Recurring Urinary Tract Infections
Official Title
H-23187: Probiotic Prophylaxis Against Recurrent Pediatric Urinary Tract Infection
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrawn by PI
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Probiotics are dietary supplements containing potentially beneficial bacterial strains such as Lactobacillus. The safety of oral administration of probiotics has been demonstrated in hundreds of studies using adults over the last 30 years. Very few studies have been conducted with children. UTI in girls occur when virulent bacteria migrate from the rectum and colonize the vagina and peri-urethral mucosa, thus gaining access to the bladder. This study will randomize girls to ARM A (probiotics + placebo) and ARM B (antibiotics + placebo) to determine if UTIs are decreased when the probiotics are given.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Urinary Tract Infection
Keywords
Urinary Tract Infection, Probiotics, Dietary Supplements, Bacteriuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARM A
Arm Type
Other
Arm Description
Probiotics drops plus placebo elixir
Arm Title
ARM B
Arm Type
Other
Arm Description
TMP/SMZ elixir plus placebo drops
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus reuteri DSM 17938
Intervention Description
DSM 17938 drops (10^8 cfu/dose of 5 drops) + placebo elixir once daily for 1 year.
Intervention Type
Drug
Intervention Name(s)
trimethoprim/sulfamethoxazole
Other Intervention Name(s)
TMP/SMZ, Bactrim, Septra
Intervention Description
Trimethoprim/sulfamethoxazole elixir (TMP/SMZ) (2 mg/kg), a standardized oral antibiotic prophylaxis, plus placebo capsule once daily for 1 year.
Primary Outcome Measure Information:
Title
The primary outcome will be the rates of bacteriuria among the subjects and the comparison of the two arms.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Girls age 1 through age 17 years of age Must have had at least 3 symptomatic UTI, uncomplicated or complicated, in the year preceding study inclusion or already using any form of prophylaxis to prevent recurrences of UTI Must have had at least 3 symptomatic urinary tract infections in the year before the start of the prophylaxis. Exclusion Criteria: Breastfeeding Pregnancy Prior adverse reaction to sulfa drugs or sulfamethoxazole/trimethoprim Known immunosuppression i.e., transplant recipients or children with congenital immunodeficiencies Poorly controlled diabetes Untreated HIV infection Use of high dose corticosteroids for autoimmune diseases or post-organ transplantation. Inhaled corticosteroids or oral steroids for asthma are allowed. Malnutrition Patients with a history of sulfamethoxazole/trimethoprim-resistant UTI will be excluded from the study Patients with renal insufficiency, liver insufficiency, or cardiopulmonary disease requiring medication will be excluded from the study Patients with known anemia will be excluded from the study Patients taking medications that may interact with sulfamethoxazole/trimethoprim will be excluded from the study Patients taking other probiotics will be excluded from the study Patients already taking prophylactic antibiotics will be excluded from the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R. Roth, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Probiotics for Girls With Recurring Urinary Tract Infections

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